NCT04357717终止不适用
Clinical Evaluation of ExoDx™ Prostate (IntelliScore) in Men With Prior Negative Prostate Biopsy Presenting for a Repeat Biopsy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in a prior negative repeat biopsy patient cohort.
研究概览
简要总结
The study is designed to confirm the performance of the ExoDx Prostate test in prior negative biopsy patients now presenting for a repeat prostate biopsy.
Note: ExoDx Prostate test results are collected for correlation to biopsy results and are not disclosed to the physician or study subject.
详细描述
Primary Endpoint:
Evaluate the correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in a prior negative repeat biopsy patient cohort.
Secondary Endpoints (exploratory):
- Evaluate the clinical performance of the ExoDx Prostate test at the cut-point of 15.6 defined for the initial biopsy patient cohort.
- Associate ExoDx Prostate test results with other ancillary studies including the use of radiographic imaging (e.g. multiparametric MRI).
- Evaluate the correlation of ExoDx Prostate as a function of risk. It is known that a higher ExoDx Prostate score correlates to a higher risk of finding prostate cancer, including HGPC, upon biopsy.
- Evaluate ExoDx Prostate with and without inclusion of standard of care parameters such as PSA, ethnicity, DRE, age and family history.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •50+ years of age
- •Clinical suspicion for prostate cancer
- •Elevated Prostate-specific Antigen between 2.0-10 ng/ mL
- •At least one (1) prior negative prostate biopsy
排除标准
- •Use of medications or hormones that are known to affect serum PSA levels within 3-6 months of study enrollment including 5-alpha-reductase inhibitors used in the treatment of an enlarged prostate gland (benign prostatic hyperplasia). Drugs in this class are finasteride (Proscar, Propecia) and dutasteride (Avodart).
- •Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment.
- •History of prostate cancer.
- •History of invasive treatments for benign prostatic hypertrophy (BPH) or lower urinary track symptoms within 6 months of study enrollment.
- •No known hepatitis status (all types) and/or HIV documented in patient's medical record.
- •Patients with history of concurrent renal/bladder tumors.
结局指标
主要结局
Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in a prior negative repeat biopsy patient cohort.
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
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